Phenom™ Catheter FG13150-0615-2SV02Recalls & reported problems
Cathera, Inc. · Phenom™ 21 Catheter · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00814584027304), received between Mar 29, 2020 and Mar 29, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Break1
- Physical Resistance/Sticking1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 29, 2020Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking
MEDTRONIC RECEIVED A REPORT THAT WHEN DEPLOYING THE PIPELINE VANTAGE, IT BECAME STUCK/LOCKED UP AT THE PHENOM MICROCATHETER HUB. THE HUB THEN DETACHED FROM THE CATHETER CORE WHICH CAUSED TWISTING IN THE PROXIMAL SECTION OF THE CATHETER AND DAMAGE TO THE PROXIMAL SECTION OF THE PIPELINE PUSHWIRE. THERE WAS NO FRICTION OR FORCE APPLIED, NO VASOSPASM, AND NO MEDICAL INTERVENTION WAS REQUIRED. REPLACEMENT PRODUCT WAS USED TO COMPLETE THE PROCEDURE, AND THERE WAS NO PATIENT HARM REPORTED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A RESIDUAL, RUPTURED ANEURYSM IN THE ANTERIOR COMMUNICATING (ACOM) ARTERY WITH A 4MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9896236 ↗
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- Chameleon CH08-40-75USMozarc Medical US LLC · Catheter, continuous flush2 recalls4 reports
- RebarTM 105-5081-153Micro Therapeutics, Inc. · Catheter, continuous flush2 deaths102 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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